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Can a Hormone-Radiation combo save erectile function in prostate cancer?

NCT ID NCT07302451

Disease control Sponsor: National Cancer Institute, Naples Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 22, 2026 · Updated 2 times

Summary

This phase 2 trial is testing whether combining a 12-month course of the hormone therapy Relugolix with precise, image-guided radiation can help men with intermediate-risk prostate cancer recover erectile function. Fifty men will receive the treatment and complete questionnaires about sexual function, quality of life, and financial impact. The main goal is to see if at least 70% of participants regain meaningful erectile function within six months of stopping hormone therapy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Relugolix (hormone therapy) and stereotactic body radiotherapy (SBRT)
What this could lead to
If successful, this approach could help men with intermediate-risk prostate cancer recover erectile function and maintain quality of life after treatment.
What could go wrong
This is a small, early-phase study with only 50 participants, so results may not apply to all patients. The hormone therapy can cause side effects like hot flashes and fatigue, and erectile recovery is not guaranteed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Feb 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male sex. (This criterion is required for the patient population being studied and for the correct data structuring in CTIS.) * Age \> 18 years; * Diagnosis of prostate cancer via transperineal core biopsy; * Classified as unfavorable intermediate-risk (T2b-2c, PSA ≤ 20 ng/mL, and Gleason score 7(4+3); ISUP grade 3); * Signed informed consent for REDI-CaP protocol; * Signed consent for REDI-CaP data processing; * Prostate volume ≤ 80 cc; * No evidence of prostate capsule invasion (documented by multiparametric MRI of the prostate); * Performance status: 0-1; * Negative total-body CT with contrast and bone scan for metastases; * Negative PSMA PET for secondary lesions; * IIEF-5 score: ≥ 8; * Patient compliance with completing periodic questionnaires and attending regular follow-ups as required by the study. Exclusion Criteria: * Have prostate cancer classified as low-risk, favorable intermediate-risk, or high-risk; * Exhibit erectile dysfunction at baseline (IIEF-5 score: \< 8); * Show positive PSMA PET results for metastases or pelvic lymph nodes; * Have capsular involvement documented by multiparametric prostate MRI; * Have contraindications to radiotherapy and/or hormone therapy; * Are unable to undergo MRI; * Cannot adhere to periodic tests and follow-ups; * Refuse or have contraindications to the implantation of intraprostatic fiducials.

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Conditions

The condition(s) this trial relates to.

adenocarcinoma prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer (adenocarcinoma)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Istituto Nazionale Tumori - IRCCS - Fondazione G. Pascale - Napoli

    RECRUITING

    Naples, 80131, Italy

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